# K140638: Propeller System - Model 2

- Pathway: 510(k) (Traditional)
- Applicant: Reciprocal Labs Corporation
- Decided: May 2, 2014 after 51 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K823423 (1982). 7 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121609: Asthmapolis System, Reciprocal Labs Corporation (2012) Summary page 1.

## Most influential descendants
- K142516: Propeller System (2015), 8 descendants of its own
- K143671: Propeller Model 2014-D Sensor (2015), 4 descendants of its own
- K152882: Propeller System (2016), 3 descendants of its own
- K161454: Propeller Sensor Model 2015-E (2016), 2 descendants of its own
- K223367: Ochsner Connected Inhaler Sensor (2023), 1 descendant of its own

## Indications for use
The Propeller System includes the Propeller MDI Model 2 Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage. The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage systemn. With the Propeller Mobile Application the user can review information collected from the MDI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers. The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their MDI and its use, to Capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and health care providers. When used under the care of a physician with a prescribed MIDI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing MIDI technique. When used under the care of a physician with a prescribed MDI, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI medications through the use of feedback such as reminders and notifications, and self-management education. The Propeller System is intended to be used in populations from Used in populations from Child (>2 years) to adult. The Propeller system can be used both indoors and outdoors; home, work and clinical settings, as well as on aircraft. The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI medication(s) by a participant. The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Propeller System is not intended for use as an MDI dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI.

Source page: https://510kreport.com/device/K140638
Methodology: https://510kreport.com/methodology